Thrombocytopenia after autologous stem cell transplantation in multiple myeloma
Conditions
Interventions
Experimental group:Subcutaneous injection of ropristom N01 from the first day after autologous stem cell transplantation: 3 ug/kg once weekly. Platelet count is measured daily for the first two weeks
Sponsors
The first affiliated hospital of anhui medical university
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult patients aged >= 18 years and diagnosed with multiple myeloma (MM); 2. All patients underwent myeloablative therapy before stem cell transplantation, and the disease remission status before transplantation >=partial response (PR); 3. Adequate organ function is required, defined as follows: 4. Serum bilirubin =40 ml/min (calculated as Cockcroft Gault); 7. LVEF by MUGA or resting echocardiography >=45%; 8. Pulmonary function (FEV1 and corrected DLCO) = 45% of predicted. 9. Adequate performance status ECOG <= 2; 10. Able to provide written informed consent; 11. Patients undergoing HDT-AHCT; 12. Patients who in the opinion of the investigator can benefit
Exclusion criteria
Exclusion criteria: 1.Patients who received thrombopoietin receptor agonists (TPO-RAs) such as romiplostim or eltrombopag within 2 months prior to enrollment; 2.Patients with concurrent conditions causing thrombocytopenia, including immune thrombocytopenia (ITP), myelodysplastic syndrome (MDS), or other related disorders; 3.Patients with a platelet count < 50×10?/L prior to transplantation; 4.Patients with severe comorbid conditions that may interfere with the clinical trial, such as renal failure requiring hemodialysis or active infections; 5.Patients with a history of symptomatic arterial thrombotic events such as myocardial infarction, ischemic cerebrovascular accident, or transient ischemic attack within the past 6 months, or those with unstable angina or heart failure; 6.Patients with a history of thromboembolic disease or those who experienced a thrombotic event within the past 6 months (not related to an interventional procedure); 7.Patients deemed by the investigator to be ineligible for participation in the trial due to other reasons;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days to platelet engraftment (defined as the first day of platelet count =20×10?/L sustained for at least 7 days);Number of platelet transfusions and total volume administered; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reaction events;Days to platelet recovery;Days to neutrophil engraftment; | — |
Countries
China
Contacts
Public ContactGe Jian
The first affiliated hospital of anhui medical university
Outcome results
None listed